About Wildgrove Clinical
We understand the challenges of developing disruptive diagnostics—especially when clinical needs, regulatory precedent, and operational realities don't align. Wildgrove brings hands-on experience from both startup and large company environments to deliver grounded, efficient, and innovative guidance.
Our Services
Comprehensive consulting services to guide your diagnostic innovation from concept through market clearance.
Clinical Development Strategy
Tailored roadmaps for first-in-class diagnostics, indication prioritization, and integrated evidence generation plans.
- Market-fit assessment
- Analytical strategy
- Evidence planning
Study Design & Execution Support
Comprehensive support from feasibility through execution with practical operational input.
- Protocol development
- Site selection
- CRO coordination
Regulatory Navigation
Expert guidance through FDA pathways including 510(k), De Novo, and CLIA-Waiver submissions.
- FDA engagement
- Q-sub strategy
- Risk mitigation
Strategic Advising
Cross-functional advisory for go-to-market readiness and real-world implementation.
- Scientific messaging
- Investor communications
- Integration planning
Why Choose Wildgrove Clinical?
Founded by a physician-scientist with extensive experience in IVD, digital health, and molecular diagnostics. We specialize in helping small and large companies design smart studies, generate compelling evidence, and navigate regulatory complexity with confidence.
Meet Our Founder
Joshua Shak, MD, PhD
Physician-scientist and industry leader with years of experience bringing diagnostic innovations to market through clinical development, regulatory strategy, and medical affairs leadership.
Roche Diagnostics
- Led clinical development for respiratory diagnostics portfolio including cobas MPXV and cobas liat systems
- Achieved Emergency Use Authorizations and 510(k) clearances
Inflammatix
- Led clinical strategy for novel emergency department diagnostic tests
- Negotiated FDA labeling language for 510(k) clearance
UCSF/SFVA
- Clinical practice in emergency medicine and internal medicine
- Founder and director of inpatient COVID unit and co-investigator on phase III therapeutic trials
Ready to Transform Your Diagnostic Innovation?
Let's discuss how Wildgrove Clinical can accelerate your path to market with expert guidance and proven strategies.
Our Approach
We begin every engagement with a complimentary discovery call to understand your unique challenges and goals. From there, we'll propose a tailored approach to help you navigate the clinical and regulatory landscape efficiently.